Drug recall
Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
FDA recall event 70224 · Class II · Maquet Cardiovascular Us Sales, Llc
Key facts
| Event ID | 70224 |
|---|---|
| Recall numbers | Z-1224-2015 |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Product type | Devices |
| Products | Servo-I ventilator system CO2 analyzer. Part number 65 23 588. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function. |
| Initiation date | Jan 12, 2015 |
| Report date | Mar 11, 2015 |
| Termination date | May 15, 2017 |
| City | Wayne |
| State | NJ |
| Country | United States |
| FEI number | 3008355164 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: